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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009835
Receipt No. R000011498
Scientific Title Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Date of disclosure of the study information 2013/01/27
Last modified on 2013/01/28

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Basic information
Public title Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Acronym The effect of monitoring urinary sodium / potassium ratio with support program
Scientific Title Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Scientific Title:Acronym The effect of monitoring urinary sodium / potassium ratio with support program
Region
Japan

Condition
Condition Hypertensive individuals
Healthy individuals
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the effect of lowering the sodium / potassium (Na/K) ratio on dietary improvement through use of a spot urine monitoring device and a conventional dietary education program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sodium / potassium ratio in 24-hour urine collections
Key secondary outcomes 1. Sodium excretion and potassium excretion in 24-hour urine collections
2. Blood pressure
3. Dietary habit by survey

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. 7 inch tablet device with dietary education software program will be installed and leaflets with dietary education information will be also handed out.
Interventions/Control_2 Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. Leaflets with dietary education information will be also handed out.
Interventions/Control_3 Conventional dietary improvement program will be applied for the control group. Leaflets with dietary education information will be handed out.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria _Healthy and hypertensive individuals
_No change on drugs at least a month for hypertensive individuals
_People who are able to use the device
_People who are able to record the result
_People who are able to participate on 24H urine collection
Key exclusion criteria _Kidney disease, CVD, DM
_Secondary hypertension
_SBP over 180mmHg, DBP over 110mmHg
_Shift workers
_People who cannot understand the dietary improvement information
Target sample size 162

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Miura
Organization Shiga University of Medical Science
Division name Department of Health Science
Zip code
Address Seta Tsukinowa-chou, Otsu, Shiga
TEL 077-548-2191
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Miura
Organization Shiga University of Medical Science
Division name Department of Health Science
Zip code
Address Seta Tsukinowa-chou, Otsu, Shiga
TEL 077-548-2191
Homepage URL
Email miura@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Omron Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Omron Healthcare Co., Ltd.
Omron Personnel Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions オムロンヘルスケア株式会社本社ビル(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 26 Day
Last follow-up date
2013 Year 03 Month 16 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 15 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 22 Day
Last modified on
2013 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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